Pharmaceutical manufacturing risk-based approaches

The risk-based approach introduced by the FDA focuses the pharmaceutical companies and regulatory authorities resources into addressing potential risk areas based on the scientific approach. The aim is to ensure pharmaceutical companies adopt new scientific developments and equipment for manufacturing safe, effective, pure, and consistent products. 

US Food and Drug Administration, Pharmaceutical current good manufacturing practices (cGMPs) for the 21st century - a risk-based approach final report, 2004. 

Management of the agency s risk-based approach encourages innovation in the pharmaceutical manufacturing sector. 

Bruttin, F. and Dean, D. (1999), A Risk-Based Approach to Reducing the Cost of Compliance in Pharmaceutical Manufacturing, Pharmaceutical Technology Europe, pp 36 4. 

US Food Drug Administration (2004) Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 2U Century - a Risk-Based Approach Final Report... 

Quality by design has received increased attention in the pharmaceutical industry since the publication of ICH guidelines ICH Q8, Q9, and QIO [12—14]. These guidelines describe a science-based approach to development of robust pharmaceutical manufacturing processes based on soimd science and predefined criteria, emphasize process understanding, and use a risk-based approach to imderstand and control the effects of manufacturing parameters on the final product. The same philosophical principles can be applied to analytical methods. That is, applying QbD principles, methods are developed by [15] ... 

Typically, the pharmaceutical industry has been reluctant to try something new due to the fear that the new approach will not find favor with the FDA. An FDA rejection would result in costly delays and processing revisions that industry is unwilling to risk. The FDA now says that this hesitancy is undesirable from a public health perspective and it would like to see more innovation introduced. According to the FDA, pharmaceutical manufacturing should be based on ... 

Process analytical technology is consistent with the quality systems approach in that it is based on science and engineering principles for assessing and mitigating risks related to poor product and process quality. In the PAT guidance, the FDA indicates that the desired state for pharmaceutical manufacturing may be characterized as follows ... 

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